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SuspendedNCT02728284Updated Jan 5, 2026

Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

An interventional study of cardiovascular MRI (CMR) and Conventional Cardiologic Evaluation in Heart Disease, sponsored by NYU Langone Health. Suspended at 1 site in United States. Open to participants aged 7 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic

Why this study was suspended
COVID-19
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
7 Years to 95 Years
Sex
All
01

Study summary

The purpose of this investigation is to evaluate newer methods of performing cardiovascular MRI (CMR) that will provide new kinds of information related to the interplay between the cardiac and the respiratory cycles, such as the interaction between the left ventricle and the right ventricle during respiration . The primary statistical objective is to provide preliminary indications of the relative utility of the investigational imaging software in terms of image quality and suitability for routine clinical use. Image quality will be expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and subjective Likert-type qualitative assessments independently provided by each of multiple blinded readers for each image. Suitability for routine use will be assessed in terms of imaging time and a binary indicator of whether, in the opinion of the investigator, adverse procedural complications (not expected) were encountered during a given imaging session.

02

Conditions studied

  • Heart Disease

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Keywords

  • Magnetic Resonance Imaging (MRI)
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects will be selected as they are scheduled for clinical MR examinations.
  • Subjects will be selected on the basis of their willingness and ability to participate, on their comprehension of the informed consent document, on their likelihood of completing the study, and on the clinical appropriateness of the investigational technique for a given patient.

Exclusion criteria

Exclusion Criteria:

  • electrical implants such as cardiac pacemakers or perfusion pumps
  • ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  • ferromagnetic objects such as jewelry or metal clips in clothing
  • pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Normal Cardiovascular System

    70 with a history of heart or lung disease

    Procedure: cardiovascular MRI (CMR)

  • Active comparator
    Abnormal Cardiovascular System

    30 without any history of heart or lung disease

    Procedure: Conventional Cardiologic Evaluation

Interventions

  • Procedurecardiovascular MRI (CMR)

    CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients

  • ProcedureConventional Cardiologic Evaluation

    ECG (gating), and respiratory motion effects

06

What researchers measure

Primary outcomes

  1. Image Quality measured by resolution

    Time frame: 10 Minutes

  2. Image Quality measured by signal to noise

    Time frame: 10 Minutes

  3. Suitability for routine use measured by imaging time and ease of use

    Time frame: 10 Minutes

07

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02728284
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Apr 5, 2016
Start date
Mar 29, 2018
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jan 5, 2026

Study contacts

Leon Axel
principal investigator · New York University Medical School

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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